The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
Time frame: four-months and twelve-months post-procedure
NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
Time frame: four-months and twelve-months post-procedure
Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
Time frame: four-months and twelve months post-procedure
Four and twelve month target vessel failure (TVF).
Time frame: Four and twelve month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.